The late phase research environment has changed dramatically in recent years. Regulators in the US and abroad are demanding a more proactive approach to safety and risk management. In light of these changes, sponsors must begin working with their strategic research partners early in the investigative process to anticipate and plan for late phase studies.
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics.
Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/
If you need any help with this presentation
The late phase research environment has changed dramatically in recent years. Regulators in the US and abroad are demanding a more proactive approach to safety and risk management. In light of these changes, sponsors must begin working with their strategic research partners early in the investigative process to anticipate and plan for late phase studies.
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics.
Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/
If you need any help with this presentation
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Mechanisms for bringing together a broad range of stakeholders that share common interests in product
innovation to increase the number of impactful therapies for skin diseases such as alopecia areata.
How to communicate scientific and medical information to patients, advocates ...jangeissler
How to communicate scientific and medical information to patients, advocates and caregivers, presented by Jan Geissler at the European Medical Writer's Symposium (EMWA) on 12 May 2016
Recent advances in patient engagement in research, including patients’ and advocates’ roles in patient
focused-drug development (PFDD) and patient-reported outcomes (PROs).
Clinical research and its importance career in clinical researchRidhimaPatel2
This document is expressing the carrier opportunities in clinical research and how it important to learn clinical research for our society and the best institute providing absolute best training for the clinical research
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Know-how of forensics science can strengthen skills pharmacists need Ajaz Hussain
The practice of Pharmacy evolving to provide real-world assurance to meet the needs and expectations of 21st Century Cures [Act].
Forensic chemistry, broadly forensic science, should be a significant part of pharmacy education to improve the global system for ensuring authenticity, availability, assurance, adherence, ….
Countering the challenge of counterfeits is only one aspect, ideally Forensic Science is a part of an integrated systems approach
Know-how of forensic science can strengthen skills pharmacists need to improve pharmacovigilance and patient satisfaction and be an important source of feedback for continually improving the global system
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Mechanisms for bringing together a broad range of stakeholders that share common interests in product
innovation to increase the number of impactful therapies for skin diseases such as alopecia areata.
How to communicate scientific and medical information to patients, advocates ...jangeissler
How to communicate scientific and medical information to patients, advocates and caregivers, presented by Jan Geissler at the European Medical Writer's Symposium (EMWA) on 12 May 2016
Recent advances in patient engagement in research, including patients’ and advocates’ roles in patient
focused-drug development (PFDD) and patient-reported outcomes (PROs).
Clinical research and its importance career in clinical researchRidhimaPatel2
This document is expressing the carrier opportunities in clinical research and how it important to learn clinical research for our society and the best institute providing absolute best training for the clinical research
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Know-how of forensics science can strengthen skills pharmacists need Ajaz Hussain
The practice of Pharmacy evolving to provide real-world assurance to meet the needs and expectations of 21st Century Cures [Act].
Forensic chemistry, broadly forensic science, should be a significant part of pharmacy education to improve the global system for ensuring authenticity, availability, assurance, adherence, ….
Countering the challenge of counterfeits is only one aspect, ideally Forensic Science is a part of an integrated systems approach
Know-how of forensic science can strengthen skills pharmacists need to improve pharmacovigilance and patient satisfaction and be an important source of feedback for continually improving the global system
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
Making sense of large data sets has always been a daunting task, and every tool that makes the life of an analyst easier is worth exploring. There are 45,000 observational studies on the CT.gov database. This is how trial version of IBM Watson visualizes the data available. The dataset was minimally processed to reflect priority information requirements, in this case insight into the most commonly used study designs over time.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Patient Recruitment and Retention in Clinical TrialClinosolIndia
Patient recruitment and retention are critical aspects of conducting successful clinical trials. Insufficient enrollment and high dropout rates can lead to delays, increased costs, and compromised study outcomes.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
Managing a rare disease or orphan drug clinical trial has several challenges. Be prepared to understand and take away real world tactical lessons to expedite these studies:
•What are the new promising techniques in clinical studies for Rare Disease research? How are the innovative areas of adaptive strategies and translational medicine being employed?
• How do patient registries and natural history studies provide insights and patients for these studies?
• What quality of life issues play into patient retention in these studies?
• How can regulatory challenges from submissions to drug approvals be met using integrated global knowledge and systems to keep a project on track?
Legal barriers to better use of health data to deliver pharmaceutical innovationOffice of Health Economics
The range of data sources and technologies relevant to pharmaceutical R&D continues to expand. In this presentation, I summarise research evaluating the main legal barriers to the better use of health data for pharmaceutical innovation, concluding that the General Data Protection Regulation (GDPR) does not create new legal barriers, and that most issues identified are in fact uncertainties rather than barriers per se. There is a strong case for industry to deal proactively with the uncertainties, sharing good practice, engendering trust and promoting a shared understanding of the value to society of pharmaceutical research.
Author(s) and affiliation(s): Amanda Cole, Office of Health Economics.
Event: CPDP 2019: Computers, Privacy and Data Protection conference
Date: 01/02/2019
Location: Brussels, Belgium
An overview of the GPC initiative that resulted in the release of best practices for ensuring validity when oncology clinical trial patients switch treatments.
Patient Perspectives on Lay Trial Results SummariesCISCRP Page
This presentation will be presented by Behtash Bahador, CISCRP's Senior Manager of Quality and Compliance at the Disclosure & Transparency for Clinical Data Summit on August 13-14, 2018. To learn more at CISCRP's Lay Summaries visit www.ciscrp.org or contact Jay Matthews at jmatthews@ciscrp.org.
Challenges and Opportunities in Conducting Multi Centre Clinical Trialsijtsrd
Conducting multi centre clinical trials presents both challenges and opportunities that significantly impact the advancement of medical research and patient care. This article explores the complex landscape of multi centre trials, highlighting the various hurdles faced by researchers and the potential benefits that can be harnessed. Challenges encompass diverse regulatory environments, logistical intricacies, and communication disparities across different sites. Harmonizing protocols, ensuring consistent data collection, and addressing ethical considerations emerge as critical obstacles. Despite these challenges, multi centre trials offer a range of opportunities, including enhanced diversity in patient populations, increased statistical power, and the potential for generalized findings. Collaborative efforts fostered through multi centre trials contribute to a broader understanding of interventions and therapies, ultimately shaping evidence based medical practices. By addressing challenges and capitalizing on opportunities, the medical research community can maximize the impact of multi centre clinical trials on patient outcomes and healthcare advancements. Deepika Thammineni | Manisha Shinde "Challenges and Opportunities in Conducting Multi-Centre Clinical Trials" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59799.pdf Paper Url:https://www.ijtsrd.com/other-scientific-research-area/other/59799/challenges-and-opportunities-in-conducting-multicentre-clinical-trials/deepika-thammineni
The information in ISR’s Electronic Media Use in Academic Medical Center Patient Recruitment report sheds light on the benefits, challenges and strategies of electronic media use for clinical trial recruitment. We are currently in an era where Facebook, Twitter, and Google searches link all of us to a larger global community. Clinical sites are actively navigating how to apply these resources to connect with patients around the world. The report will help academic medical centers, site personnel and CRO/sponsors understand which channels and strategies will best help accomplish their recruitment goals, and which ones can be developed for increased success in this realm.
Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging ...Medpace
Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
COVID-19 Product Development and Clinical Trials: Considerations from Europea...Medpace
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint ...Medpace
n this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.
Getting Ahead of the Evolving Landscape in RadiopharmaceuticalsMedpace
In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.
Challenges and Considerations in Clinical Development of "Targeted Therapies"...Medpace
In this webinar, Medpace experts discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
1. FOCUSED. TRUSTED. GLOBAL.
Planning and Executing a Late
Phase Trial: Setting Expectations
and Maximizing Outcomes
Alexander Artyomenko MD PhD
3rd Annual Outsourcing in Clinical Trials Europe
Zurich, 14 May 2013
2. FOCUSED. TRUSTED. GLOBAL.
o Key objectives and critical
differences of Late Phase research
o Early planning: maximizing
product potential
o Selecting a strategic partner:
benefits and considerations
3. FOCUSED. TRUSTED. GLOBAL.
Example definitions
Late Phase Studies
o Any study conducted on a marketed, fully approved
product
o Studies capturing clinical data and addressing real world
issues of safety, effectiveness, health outcomes,
reimbursement and risk management
4. FOCUSED. TRUSTED. GLOBAL.
Late Phase Research Objectives
o Long-term real-world safety data and risk
management
FDA/EMA mandated
Adverse claims
New endpoints, health outcomes, effectiveness
o Maximize market penetration
New comparators and dosage forms
Label extension
o Provide access to yet unregistered drugs
EAP/Named Patient/Compassionate use studies
o Health economics and Patient Reported Outcomes
Reimbursement
5. FOCUSED. TRUSTED. GLOBAL.
Interventional/Non-interventional
Late Phase Study Types
o Randomized Clinical Trials
o Observational epidemiologic studies
o Expanded Access Programs
o Post-Authorization Safety/Efficacy studies
o Health Economics and Patient-Reported Outcomes
o Product and disease registries
6. FOCUSED. TRUSTED. GLOBAL.
Regulatory Framework
o GCP and GPP
o ISPE Guidelines for GPP
o CIOMS International Ethical Guidelines for Epidemiological
Studies
o Eudralex Volume 9A: Guidelines on Pharmacovigilance for
Medicinal Products for Human Use
o GRACE Principles
o Country-specific HEOR guidelines
o No harmonized legal framework across countries due to a
lower risk to subjects
o High emphasis on scientific credibility and data protection
7. FOCUSED. TRUSTED. GLOBAL.
Phase II/III vs. Late Phase
o Objectives
o Protocol design
o Study Population
o Sites outreach
o Data collection
o Regulatory documents and submissions
o Site agreements
o Monitoring
8. FOCUSED. TRUSTED. GLOBAL.
Late Phase Studies/Non-interventional
o Capture real-world data/standard of care
o Analyse data from a large number of patients
o Less per patient costs than in a clinical trial
o Increase disease and/or drug awareness
o Hypotheses generation and academic
research support
o Create and support stakeholder relationships
9. FOCUSED. TRUSTED. GLOBAL.
Challenges
Late Phase Studies/Non-interventional
o Attributing causality to outcomes
o Retrospective and prospective data
collection
o Diversity of regulation, standards of care
and cultures
12. FOCUSED. TRUSTED. GLOBAL.
Clinical to Commercial
o Know the Stakeholders
o Research unmet needs
o Understand diverse objectives
o Consider industry advances
13. FOCUSED. TRUSTED. GLOBAL.
Engaging Broader Audience
o Phase I/II Safety vs. Long-term Safety
Outcomes
o Efficacy vs. Effectiveness
Real-World Data
o Cost and Value
Compliance
Health Economics
14. FOCUSED. TRUSTED. GLOBAL.
Maximize Study Potential
o Focus on key objectives
Impact on design, timelines, risks and costs
o Consider designs
Follow-up extensions
Health Economics and Patient-reported outcomes
Genetic/biomarker testing
o Target geographies
Market access
KOL support
Product launch
15. FOCUSED. TRUSTED. GLOBAL.
Starting Up
o Feasibility
o Start-up timelines
o Product approval status
o Submission requirements
o Site communication and training
16. FOCUSED. TRUSTED. GLOBAL.
Monitoring
o Risk assessment during
protocol development
o Focus on patient safety and
data quality
o Targeted on-site activities
o Timely data entry
o Remote site management
o Patient recruitment…and
retention!
18. FOCUSED. TRUSTED. GLOBAL.
Data Management
o Electronic Data Capture
o Electronic Health Records
o Direct Data Entry by patients
o Multiple data sources
o Large data volumes
19. FOCUSED. TRUSTED. GLOBAL.
Safety Reporting
o Increased demand for real-world safety data
o Focus on the events of special interest, SAEs
and SUSARs
o Data mining beyond trials
21. FOCUSED. TRUSTED. GLOBAL.
Selecting a Strategic Research Partner
o Therapeutic expertise
o Local knowledge and global reach
o Broad scope of services
o Prior positive experience
o Operational expertise and efficiencies
o Market access expertise
o Greater flexibility
22. FOCUSED. TRUSTED. GLOBAL.
Continuous Collaboration
o Facilitates early planning
o Leverages previous learning
o Ensures process clarity
o Utilizes innovative technologies
o Streamlines project execution
o Maintains organizational focus
Saves time and money!
23. FOCUSED. TRUSTED. GLOBAL.
Late Phase Research
o Therapeutic, regulatory and operational
expertise is essential
o Diverse objectives require early planning
o Strategic partnership brings significant
efficiencies to all stakeholders